Nalu Neurostimulation System

K183047 · Boston Scientific Neuromodulation · GZB · Mar 22, 2019 · Neurology

Device Facts

• Record ID: K183047
• Device Name: Nalu Neurostimulation System
• Applicant: Boston Scientific Neuromodulation
• Product Code: GZB · Neurology
• Decision Date: Mar 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nalu Neurostimulation System is indicated as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

Device Story

Nalu Neurostimulation System provides spinal cord stimulation for chronic, intractable pain. System components: miniature implantable pulse generator (IPG), leads, surgical tools, externally worn Therapy Discs, and clinician/patient software applications. IPG delivers pulsed electrical current to spinal cord nerves to inhibit pain signals. Therapy Discs (worn by patient) power and command the IPG wirelessly via 40.68 MHz RF transmission. Clinician uses Android tablet app to configure therapy parameters; patient uses mobile app (iOS/Android) for basic control (on/off, profile selection). Used in clinical and home settings. Benefits include therapeutic pain relief. System supports periodic dosing and fine-tuning of pulse patterns.

Clinical Evidence

No clinical data. Evidence consists of bench testing (electrical, mechanical, software verification/validation), biocompatibility testing (ISO 10993-1), and a 90-day porcine animal study evaluating surgical usability, RF communication, device stability, and tissue response. All bench and animal testing met pre-defined specifications.

Technological Characteristics

Active implantable neurostimulator. IPG: ceramic enclosure, polyurethane/silicone encapsulation. Leads: 8-electrode Pt/Ir array, polyurethane insulation. Power: 40.68 MHz RF wireless transmission from external Therapy Disc. Therapy: charge-balanced, delayed biphasic, asymmetrical waveforms; 2-1500 Hz frequency; 12-1000 μs pulse width. Connectivity: Bluetooth Low Energy for clinician/patient apps. Sterilization: Ethylene Oxide. Software: Moderate level of concern.

Indications for Use

Indicated for patients with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain, as a sole mitigating agent or adjunct to other therapies. Trial devices are indicated for trial stimulation up to 30 days to determine efficacy.

Regulatory Classification

Identification

An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

Predicate Devices

• Freedom SCS System (K170141)

Reference Devices

• Stimwave Freedom SCS System (K141399)
• Medtronic Mattrix 3271/3272 (K934065)
• Medtronic Xtrel 3425 (K883780)
• ANS Renew (K000852)

Submission Summary (Full Text)

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March 22, 2019

Nalu Medical, Inc Michele Chin-Purcell Vice President RA/QA 1525 Faraday Ave. Suite 180 Carlsbad, California 92008

Re: K183047

Trade/Device Name: Nalu Neurostimulation System Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZB Dated: February 17, 2019 Received: February 21, 2019

Dear Michele Chin-Purcell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Pamela D. Scott -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K183047

Device Name Nalu Neurostimulation System

#### Indications for Use (Describe)

The Nalu Neurostimulation System is indicated as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.

The trial devices are solely used for trial stimulation (no longer thank 30 days) to determine efficacy before recommendation for a permanent (long term) device.

| Type of Use (Select one or both, as applicable) | | | | | |
|--------------------------------------------------|---------------------------------------------|--|--|--|--|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | | | | |

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# 5.1. Submission Sponsor

Nalu Medical, Incorporated 2320 Faraday Ave., Suite 100 Carlsbad, CA 92009 Phone: [phone] Fax: [phone] Contact: Michele Chin-Purcell, Vice President of Regulatory Affairs and Quality Assurance

# 5.2. Date Prepared

March 20, 2019

# 5.3. Device Identification

Trade/Proprietary Name: Nalu Neurostimulation System Common/Usual Name: Spinal Cord Stimulator Product Code: GZB Regulation number: 21 CFR 882.5880: Stimulator, spinal-cord, implanted (Pain Relief) Class: Class II Device Classification Panel: Neurology

# 5.4. Legally Marketed Predicate Device(s)

Freedom SCS System (K170141) by Stimwave Technologies, Inc. Hereafter, also referred to as the Stimwave Freedom SCS System.

In addition, references are made to other 510(k) devices that were used as part of the predicate history to the primary predicate in this submission. This history of the predicates is summarized in Table 5-1:

| Device | 510(k) | Predicate(s) used for clearance |
|-----------------------------|---------|-------------------------------------------------------------------------------------------------|
| Stimwave Freedom SCS System | K141399 | Medtronic Mattrix 3271/3272 (K934065)<br>Medtronic Xtrel, 3425 (K883780)<br>ANS Renew (K000852) |
| Stimwave Freedom SCS System | K150517 | K141399 |
| Stimwave Freedom SCS System | K160600 | K150517 |
| Stimwave Freedom SCS System | K162161 | K160600 |

Table 5-1: Predicate history of the proposed primary predicate

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| Stimwave Freedom SCS System<br>(Primary Predicate) | K170141 | K162161 |
|----------------------------------------------------|---------|---------|
|----------------------------------------------------|---------|---------|

The 510(k) history of the Stimwave device includes design changes over time. The original Medtronic and ANS devices are part of the predicate history of the Stimwave device and are also used as reference devices in this document.

# 5.5. Device Description

The Nalu Neurostimulation system (also referred to as the "Nalu System") is used for spinal cord stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral or bilateral pain. The Nalu Neurostimulation system incorporates a miniature implanted neurostimulator, powered by an externally worn device. Similar to the predicate Stimwave system, the Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord to inhibit the transmission of pain signals to the brain. The Nalu System is implanted only following a successful trial period using the Nalu Neurostimulation trial system.

The Nalu Neurostimulation System is comprised of 5 elements:

| 1. | Nalu<br>Implantable<br>Pulse<br>Generator | The implantable pulse generator (IPG) provides electrical<br>stimulation pulses that are transmitted through the leads, through<br>the dura, to the desired spinal cord site. The IPG is available in two<br>different implant architectures: an “integrated" system with pre-<br>attached leads and a "ported" system where leads may be attached,<br>via connector ports. In addition, both of these versions are available<br>in single or dual lead configurations. The hermetic IPG housing<br>includes a ceramic enclosure and a feedthrough connected internally<br>to a printed circuit board assembly. Wires leaving the IPG are<br>encapsulated in polyurethane and a silicone over mold forms the<br>final biocompatible surface of the IPG for direct patient tissue<br>contact. |
|----|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 2. Leads | Leads are implantable and are designed to deliver electrical pulses<br>to the spinal cord in the epidural space via an array of eight<br>cylindrical electrodes at the distal end. Leads may be integrated<br>with or connected to the IPG. Both Trial and Permanent Implant<br>leads are available for use. The leads use polyurethane insulation<br>with Pt/Ir electrodes. The leads may be secured in place with the<br>Nalu Lead Anchor. |
| 3. | Surgical and<br>Trial Tools | Implantation of the Nalu IPG and lead components for Spinal Cord<br>Stimulation (SCS) is performed via standard SCS surgical<br>techniques. Epidural space is accessed via epidural needle<br>placement with the loss of resistance technique, followed by lead<br>placement through an introducer. The leads are anchored and the |

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| | IPG is placed in a subcutaneous pocket. Patient contacting materials include medical grade stainless steel, thermoplastic elastomers, ABS, silicone, and Urethane. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4. Externally worn Therapy Discs | Two types of Therapy Disc are available. One is to be used during the trial phase (Trial Therapy Disc), and one is to be used after permanent IPG implantation (Therapy Disc). Both devices are worn by the patient using one of Nalu-provided options. The Therapy Discs house a rechargeable lithium ion battery, and electronics including a microcontroller running software for therapy control, patient interaction and communication with Nalu's clinician programmer and remote-control devices. The Therapy Disc used to power and command the implant does so wirelessly using Radio Frequency (RF) and is held in place by an adhesive clip applied to the skin or a belt worn against the skin or over clothing. |
| 5. Programmer, Remote | A Clinician Programmer Application is provided to configure the Trial Therapy Disc and Therapy Disc devices during surgery and programming. A Patient Remote Control Application is issued to provide the patient with a convenient secondary option to control their system in addition to the built-in controls on the Therapy Disc. |
| | The Clinician Programming Application runs on an Android tablet and communicates over a secure Bluetooth Low Energy link with the Trial Therapy Disc and Therapy Disc devices. The programmer is responsible for configuring the devices to deliver therapy according to clinician defined levels and patient preferences, and for managing patient and session records. |
| | The Patient Remote Control Application runs on iOS and Android platforms and offers basic control of the Trial Therapy Disc and Therapy Disc through a secure Bluetooth Low Energy link. The controls include selecting between physician-defined therapy options. turning stimulation on and off. and managing alerts. |

# 5.6. Indications for Use Statement

"The system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.

The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device."

The Indications for Use statement for the Nalu Neurostimulation System is not identical to the predicate device; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the

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predicate. Both the subject and predicate devices have the same intended use for the stimulation of the spinal cord for treatment of chronic, intractable pain.

# 5.7. Substantial Equivalence Discussion

The following tables compare the Nalu Neurostimulation System to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

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### Table 5-2: Substantial Equivalence Table – General and Implanted Components

| | Nalu<br>Neurostimulation<br>System<br>(Subject Device) | Stimwave<br>Freedom-8 SCS<br>system<br>(Primary<br>Predicate) | Stimwave<br>Freedom SCS<br>system<br>(Reference<br>Device) | Medtronic Mattrix<br>3271/3272<br>(Reference<br>Device) | Medtronic Xtrel<br>3425<br>(Reference<br>Device) | ANS Renew<br>(Reference<br>Device) | Analysis of<br>Technological<br>Differences from<br>Primary Predicate |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| 510(k) | TBD | K170141 | K141399 | K934065 | K883780 | K000852 | NA |
| Product Code and<br>class | GZB, Class II | Same | Same | Same | Same | Same | |
| Regulation number | 21 CFR 882.5880 | Same | Same | Same | Same | Same | |
| Classification name | Implanted spinal<br>cord stimulator for<br>pain relief. | Same | Same | Same | Same | Same | |
| Intended Use | Stimulation of<br>spinal cord for<br>chronic, intractable<br>pain | Same | Same | Same | Same | Same | |
| Indications for Use | The Nalu<br>Neurostimulation<br>System is indicated<br>as the sole<br>mitigating agent,<br>or as an adjunct to<br>other modes of<br>therapy used in a<br>multidisciplinary<br>approach for<br>chronic, intractable<br>pain of the trunk<br>and/or limbs, | The Freedom Spinal Cord Stimulator<br>(SCS) System is intended as the sole<br>mitigating agent, or as an adjunct to<br>other modes of therapy used in a<br>multidisciplinary approach for chronic,<br>intractable pain of the trunk and/or<br>lower limbs, including unilateral or<br>bilateral pain.<br>The Freedom-8A Trial Lead Kit is only<br>used in conjunction with the Freedom-<br>8A Stimulator Receiver Kit, and the<br>Freedom-4A Trial Lead Kit is used for<br>either the Receiver Kit Freedom-4A<br>Stimulator or the Receiver Kit Freedom- | | Indicated as an aide in the management<br>of chronic, intractable pain of the trunk<br>or limbs | | Indicated for the<br>treatment of<br>chronic pain of<br>trunk and limbs,<br>either as the<br>sole mitigating<br>agent, or as an<br>adjunct to other<br>modes of<br>therapy used in<br>a<br>multidisciplinary<br>approach. | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| | Nalu<br>Neurostimulation<br>System<br>(Subject Device) | Stimwave<br>Freedom-8 SCS<br>system<br>(Primary<br>Predicate) | Stimwave<br>Freedom SCS<br>system<br>(Reference<br>Device) | Medtronic Mattrix<br>3271/3272<br>(Reference<br>Device) | Medtronic Xtrel<br>3425<br>(Reference<br>Device) | ANS Renew<br>(Reference<br>Device) | Analysis of<br>Technological<br>Differences from<br>Primary Predicate |
| | including unilateral<br>or bilateral pain.<br>The trial devices<br>are solely used for<br>trial stimulation<br>(no longer than 30<br>days) to determine<br>efficacy before<br>recommendation<br>for a permanent<br>(long term) device. | 8A Stimulator. The trial devices are solely<br>used for trial stimulation (no longer than<br>30 days) to determine efficacy before<br>recommendation for a permanent (long<br>term) device. | | | | | |
| Prescription Use? | Yes | Same | Same | Same | Same | Same | Same |
| Anatomical site | Epidural space | Same | Same | Same | Same | Same | Same |
| Environmental Use | Hospital, Home | Same | Same | Same | Same | Same | Same |
| Intended Clinician | Orthopedic,<br>Neurosurgeon,<br>Anesthesiologist | Same | Same | Same | Same | Same | Same |
| Intended User | Physician,<br>Layperson | Same | Same | Same | Same | Same | Same |
| Mode of Action | Radio Frequency<br>(RF) wireless<br>transmission of<br>energy to produce<br>stimulation at<br>stimulator<br>electrodes. | Same | Same | Same | Same | Same | Same |
| | Nalu<br>Neurostimulation<br>System<br>(Subject Device) | Stimwave<br>Freedom-8 SCS<br>system<br>(Primary<br>Predicate) | Stimwave<br>Freedom SCS<br>system<br>(Reference<br>Device) | Medtronic Mattrix<br>3271/3272<br>(Reference<br>Device) | Medtronic Xtrel<br>3425<br>(Reference<br>Device) | ANS Renew<br>(Reference<br>Device) | Analysis of<br>Technological<br>Differences from<br>Primary Predicate |
| Software Level of<br>Concern | Moderate | Moderate | Moderate | Unreported | Unreported | Moderate | Same |

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| | Nalu Neurostimulation<br>System<br>(Subject Device) | Stimwave Freedom SCS<br>system<br>(K170141)<br>(Primary Predicate) | Stimwave Freedom<br>SCS system<br>(K141399)<br>(Reference Device) | Medtronic<br>Mattrix<br>3271/3272<br>(K934065)<br>(Reference<br>Device) | Medtronic<br>Xtrel 3425<br>(K883780)<br>(Reference<br>Device) | ANS Renew<br>(K000852) | Analysis of<br>Technological<br>Differences from<br>Primary<br>Predicate |
|-----------------------------------|--------------------------------------------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------|---------------------------------------------------------------|-----------------------------------|-----------------------------------------------------------------------------|
| IPG | | | | | | | |
| Dimensions | Lead = 1.30 mm diameter<br>IPG = 28 x 11 x 4.9 mm | Integrated with lead body,<br>1.35 mm diameter | Integrated with<br>lead body, 1.35<br>mm diameter | Details unavailable | Details unavailable | Details unavailable | Differences do<br>not affect safety<br>and effectiveness<br>of intended use |
| Housing<br>material | Silicone and Pellethane<br>2363-55D | Pellethane 2363-55D | Pellethane 2363-<br>55D | Details unavailable. | Details unavailable. | Details unavailable. | Differences do<br>not affect safety<br>and effectiveness<br>of intended use |
| Implant<br>location | Lead: Epidural space<br>IPG: Subcutaneous, mid<br>back | Epidural space and<br>Subcutaneous, mid back | Same | Same | Same | Same | Same |
| Electrical<br>components | Embedded receiver,<br>flexible circuit board | Same | Same | Sealed<br>electronic<br>circuits | Sealed<br>electronic<br>circuits | Sealed<br>electronic<br>circuits | Same |
| Power Delivery | Coupled receiver radio<br>frequency transmission | Same | Same | Same | Same | Coupled<br>receiver,<br>hardwired | Same |
| | Nalu Neurostimulation<br>System<br>(Subject Device) | Stimwave Freedom SCS<br>system<br>(K170141)<br>(Primary Predicate) | Stimwave Freedom<br>SCS system<br>(K141399)<br>(Reference Device) | Medtronic<br>Mattrix<br>3271/3272<br>(K934065)<br>(Reference<br>Device) | Medtronic<br>Xtrel 3425<br>(K883780)<br>(Reference<br>Device) | ANS Renew<br>(K000852) | Analysis of<br>Technological<br>Differences from<br>Primary<br>Predicate |
| | | | | | | with<br>connector | |
| Lead | | | | | | | |
| Electrode<br>Material | Platinum-iridium 90:10 | Same | Same | Same | Same | Same | Same |
| Insulation Body<br>Material | Pellethane 2363-55D | Same | Same | Same | Same | Same | Same |
| Cable features | Multilumen tube | Same | Same | Coiled Wires | Coiled Wires | Braided Wire | Same |
| Lead length | 40 cm, 60 cm | 44 cm | 45 cm | 30 to 110 cm | 30 to 110 cm | 30 and 60 cm | Differences do<br>not affect safety<br>and effectiveness<br>of intended use |
| Diameter | 1.30 mm | 1.35 mm | 1.35 mm | 1.3 mm | 1.3 mm | 1.37 mm | Differences do<br>not affect safety<br>and effectiveness<br>of intended use |
| Electrode Array<br>length | 52 mm | 24 mm (FRE-4)<br>52 mm (FRE-8) | 24 mm | 24 mm | 24 mm | 24 mm | Differences do<br>not affect safety<br>and effectiveness<br>of intended use |
| No. of<br>Electrodes, per<br>lead | 8 | 4 (FRE-4)<br>8 (FRE-8) | 4 | Same | Same | 4 or 8 | Differences do<br>not affect safety<br>and effectiveness<br>of intended use |
| Individual<br>Electrode<br>length | 3.0 mm | Same | Same | Same | Same | Same | Same |
| | Nalu Neurostimulation<br>System<br>(Subject Device) | Stimwave Freedom SCS<br>system<br>(K170141)<br>(Primary Predicate) | Stimwave Freedom<br>SCS system<br>(K141399)<br>(Reference Device) | Medtronic<br>Mattrix<br>3271/3272<br>(K934065)<br>(Reference<br>Device) | Medtronic<br>Xtrel 3425<br>(K883780)<br>(Reference<br>Device) | ANS Renew<br>(K000852) | Analysis of<br>Technological<br>Differences from<br>Primary<br>Predicate |
| Electrode<br>spacing | 4.0 mm | Same | Same | Same | Same | Same | Same |
| Electrode<br>surface area | 12.25 mm² | 12.72 mm² | 12.72 mm² | 12.25 mm² | 12.25 mm² | ~13 mm² | Differences do<br>not affect safety<br>and effectiveness<br>of intended use |
| Lead extension | Lead extension available | NA | NA | Lead extension<br>available | Lead extension<br>available | Lead<br>extension<br>available | Differences do<br>not affect safety<br>and effectiveness<br>of intended use |
| Lead Anchor | Molded silicone anchor<br>with Ti locking mechanism | Suture Sleeve Cap,<br>Pellethane 55-D, placed<br>over proximal end of<br>stimulator | Suture Sleeve Cap,<br>Pellethane 55-D,<br>placed over<br>proximal end of<br>stimulator | Molded silicone<br>anchor | Molded<br>silicone anchor | Molded<br>silicone<br>anchor | Differences do<br>not affect safety<br>and effectiveness<br>of intended use |
| Configurations | Integrated and with Ports | Integrated | Integrated | With Ports | With Ports | With Ports | Differences do<br>not affect safety<br>and effectiveness<br>of intended use |
| Sterilization | Ethylene Oxide | Same | Same | Same | Same | Same | Same |

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### Table 5-3: Substantial Equivalence Table - Therapy

| Comparator | Nalu<br>Neurostimulation<br>System<br>(Subject Device) | Stimwave Freedom<br>SCS system<br>(K170141)<br>(Primary Predicate) | Stimwave Freedom<br>SCS system<br>(K141399)<br>(Reference Device) | Medtronic Mattrix<br>3271/3272<br>(K934065)<br>(Reference Device) | Medtronic<br>Xtrel 3425<br>(K883780)<br>(Reference<br>Device) | ANS Renew<br>(K000852)<br>(Reference<br>Device) | Analysis of<br>Technological<br>Differences from<br>Primary Predicate |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------|-------------------------------------------------|-----------------------------------------------------------------------------|
| | | | | | | | |
| Pulse Frequency | 2 Hz to 1500 Hz | 5 to 1500 Hz | 2 Hz to 1500 Hz | 5 to 240 Hz | 5 to 1400 Hz | 10 to 1500 Hz | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Pulse Width | 12 to 1000 μs | 49 to 500 μs | 50 to 500 μs | 50 to 500 μs | 50 to 1000 μs | 50 to 500 μs | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Current/Voltage<br>Regulated | Current | Current | Current | Voltage | Voltage | Current | Same |
| Output Voltage<br>(300 Ohms) | 0 to 3.1 V | 0 to 4.1 V | 0 to 6.3 V | 0 to 7 V | 0 to 5.4 V | 0 to 5.7 V | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Output Voltage<br>(500 Ohms) | 0 to 5.1 V | 0 to 6.4 V | 0 to 7.2 V | 0 to 10.8 V | 0 to 7.1 V | 0 to 7.6 V | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Output Voltage<br>(800 Ohms) | 0 to 8.2 V | 0 to 7.5 V | 0 to 8.0 V | 0 to 11.6 V | 0 to 8.4 V | 0 to 9.6 V | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Output Current<br>(300 Ohms) | 0 to 10.2 mA | 0 to 13.5 mA | 0 to 21 mA | 0 to 23.3 mA | 0 to 18.0 mA | 0 to 19.0 mA | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Comparator | Nalu<br>Neurostimulation<br>System<br>(Subject Device) | Stimwave Freedom<br>SCS system<br>(K170141)<br>(Primary Predicate) | Stimwave Freedom<br>SCS system<br>(K141399)<br>(Reference Device) | Medtronic Mattrix<br>3271/3272<br>(K934065)<br>(Reference Device) | Medtronic<br>Xtrel 3425<br>(K883780)<br>(Reference<br>Device) | ANS Renew<br>(K000852)<br>(Reference<br>Device) | Analysis of<br>Technological<br>Differences from<br>Primary Predicate |
| Output Current<br>(500 Ohms) | 0 to 10.2 mA | 0 to 12.8 mA | 0 to 15 mA | 0 to 21.6 mA | 0 to 14.2 mA | 0 to 15.2 mA | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Output Current<br>(800 Ohms) | 0 to 10.2 mA | 0 to 9.4 mA | 0 to 10 mA | 0 to 14.5 mA | 0 to 10.5 mA | 0 to 12.0 mA | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Waveform | charge balanced<br>(delayed) biphasic<br>asymmetrical | Same | Same | Same | Same | Same | Same |
| Pulse Shape | Decaying<br>Exponential | Decaying<br>Exponential | Decaying<br>Exponential | Decaying<br>Exponential | Decaying<br>Exponential | Decaying<br>Exponential | Same |
| Maximum phase<br>charge (300 Ohms) | 10.2 µC/pulse | 6.8 µC/pulse | 10.5 µC/pulse | 11.7 µC/pulse | 18.0 µC/pulse | 9.5 µC/pulse | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Maximum phase<br>charge (500 Ohms) | 10.2 µC/pulse | 6.4 µC/pulse | 7.2 µC/pulse | 10.8 µC/pulse | 14.2 µC/pulse | 7.6 µC/pulse | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Maximum phase<br>charge (800 Ohms) | 10.2 µC/pulse | 4.7 µC/pulse | 5.0 µC/pulse | 7.3 µC/pulse | 10.5 µC/pulse | 6.0 µC/pulse | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Maximum charge<br>density (300 Ohm) | 83.3 µC/cm² | 53.1 µC/cm² | 82.5 µC/cm² | 97.2 µC/cm² | 150.0 µC/cm² | 73.1 µC/cm² | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Comparator | Nalu<br>Neurostimulation<br>System<br>(Subject Device) | Stimwave Freedom<br>SCS system<br>(K170141)<br>(Primary Predicate) | Stimwave Freedom<br>SCS system<br>(K141399)<br>(Reference Device) | Medtronic Mattrix<br>3271/3272<br>(K934065)<br>(Reference Device) | Medtronic<br>Xtrel 3425<br>(K883780)<br>(Reference<br>Device) | ANS Renew<br>(K000852)<br>(Reference<br>Device) | Analysis of<br>Technological<br>Differences from<br>Primary Predicate |
| Maximum charge<br>density (500 Ohm) | 83.3 µC/cm² | 50.3 µC/cm² | 56.6 µC/cm² | 90.0 µC/cm² | 118.3 µC/cm² | 58.5 µC/cm² | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Maximum charge<br>density (800 Ohm) | 83.3 µC/cm² | 36.9 µC/cm² | 39.3 µC/cm² | 60.4 µC/cm² | 87.5 µC/cm² | 46.2 µC/cm² | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Maximum current<br>density (300 Ohm) | 83.3 mA/cm² | 106.1 mA/cm² | 165.1 mA/cm² | 194.4 mA/cm² | 150.0<br>mA/cm² | 146.2 mA/cm² | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Maximum current<br>density (500 Ohm) | 83.3 mA/cm² | 100.6 mA/cm² | 113.2 mA/cm² | 180.0 mA/cm² | 118.3<br>mA/cm² | 116.9 mA/cm² | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Maximum current<br>density (800 Ohm) | 83.3 mA/cm² | 78.6 mA/cm² | 78.6 mA/cm² | 120.8 mA/cm² | 87.5 mA/cm² | 92.3 mA/cm² | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Net Charge | 0 µC | Same | Same | Same | Same | Same | Same |
| Average Phase<br>Power (300 Ohms) | 0.031 W/phase | 0.053 W/phase | 0.060 W/phase | 0.132 W/phase | 0.068<br>W/phase | 0.070 W/phase | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Average Phase<br>Power (500 Ohms) | 0.052 W/phase | 0.073 W/phase | 0.076 W/phase | 0.166 W/phase | 0.074<br>W/phase | 0.090 W/phase | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Average Phase<br>Power (800 Ohms) | 0.083 W/phase | 0.062 W/phase | 0.060 W/phase | 0.131 W/phase | 0.066<br>W/phase | 0.100 W/phase | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Comparator | Nalu<br>Neurostimulation<br>System<br>(Subject Device) | Stimwave Freedom<br>SCS system<br>(K170141)<br>(Primary Predicate) | Stimwave Freedom<br>SCS system<br>(K141399)<br>(Reference Device) | Medtronic Mattrix<br>3271/3272<br>(K934065)<br>(Reference Device) | Medtronic<br>Xtrel 3425<br>(K883780)<br>(Reference<br>Device) | ANS Renew<br>(K000852)<br>(Reference<br>Device) | Analysis of<br>Technological<br>Differences from<br>Primary Predicate |
| Average Phase<br>Power density (300<br>Ohms) | 0.25 W/cm2/phase | 0.42 W/cm2/phase | 0.48 W/cm2/phase | 1.10 W/cm2/phase | 0.57<br>W/cm2/phase | 0.54<br>W/cm2/phase | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Average Phase<br>Power density (500<br>Ohms) | 0.51 W/cm2/phase | 0.58 W/cm2/phase | 0.59 W/cm2/phase | 1.38 W/cm2/phase | 0.62<br>W/cm2/phase | 0.69<br>W/cm2/phase | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Average Phase<br>Power density (800<br>Ohms) | 0.55 W/cm2/phase | 0.48 W/cm2/phase | 0.60 W/cm2/phase | 1.09 W/cm2/phase | 0.55<br>W/cm2/phase | 0.77<br>W/cm2/phase | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Pulse Delivery<br>Mode | Continuous | Same | Same | Same | Same | Same | Same |
| Current Path<br>options | Bipolar | Bipolar | Bipolar | Bipolar | Bipolar | Bipolar | Same |
| Program Cycle | Cycle through<br>programs | Same | Details unavailable | Details unavailable | Details<br>unavailable | Details<br>unavailable | Same |
| Pulse Pattern | Fine tuning of pulse<br>patterns<br>(On/Off; If On, spans<br>from 12 μs to 1000<br>µs) | Same | Details unavailable | Details unavailable | Details<br>unavailable | Details<br>unavailable | Same |
| Dosage Time | Allows for<br>stimulation to be<br>applied in periodic<br>doses (On/Off; If<br>On, spans from 1 ms<br>to 25 ms) | Same (over span of<br>several minutes,<br>hours, and up to<br>one day) | Details unavailable | Same (Cycle<br>ON/OFF) | Same (Cycle<br>ON/OFF) | Details<br>unavailable | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Comparator | Nalu<br>Neurostimulation<br>System<br>(Subject Device) | Stimwave Freedom<br>SCS system<br>(K170141)<br>(Primary Predicate) | Stimwave Freedom<br>SCS system<br>(K141399)<br>(Reference Device) | Medtronic Mattrix<br>3271/3272<br>(K934065)<br>(Reference Device) | Medtronic<br>Xtrel 3425<br>(K883780)<br>(Reference<br>Device) | ANS Renew<br>(K000852)<br>(Reference<br>Device) | Analysis of<br>Technological<br>Differences from<br>Primary Predicate |
| Daily Therapy Time | Limits the number of<br>hours in a day that<br>stimulation may be<br>used<br>(Seconds to hours) | Same (hours) | Details unavailable | Details unavailable | Details<br>unavailable | Details<br>unavailable | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| Transmit<br>Frequency | 40.68 MHz | 915 MHz | 915 MHz | 2 MHz | 1.6 MHz | 2 MHz | Differences do not<br>affect safety and<br>effectiveness of<br>intended use |

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